FDA 510(k) Microbiology Devices
FDA 510(k) Microbiology Devices - Regulatory Overview
FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.
Key device types:
- Blood culture systems - automated incubation and detection platforms
- Microbial identification - MALDI-TOF, biochemical and molecular ID systems
- Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
- Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
- Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens
7048
Total
6986
Cleared
159d
Avg (2y)
1976
Since
1404 Microbiology devices
Cleared
Apr 29, 2022
Alinity m STI Assay
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
576d
Not Cleared
Apr 29, 2022
BioFire Joint Infection (JI) Panel
QSN
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
549d
Cleared
Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
PEN
Gram-negative Bacteria And Associated Resistance Markers
209d
Cleared
Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
113d
Cleared
Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
GTY
Antigens, All Groups, Streptococcus Spp.
210d
Cleared
Mar 15, 2022
VITEK MS PRIME
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
221d
Cleared
Feb 25, 2022
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
148d
Cleared
Feb 09, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
209d
Cleared
Feb 04, 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
150d
Cleared
Feb 02, 2022
NATtrol BD MAX Vaginal Panel External Controls
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
615d
Cleared
Jan 19, 2022
MDx-Chex for BCID2
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
156d
Cleared
Dec 27, 2021
Colibri System
QQV
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
775d
Cleared
Dec 23, 2021
Curian Campy
LQP
Campylobacter Spp.
266d
Cleared
Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
JWY
Manual Antimicrobial Susceptibility Test Systems
363d
Cleared
Dec 17, 2021
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
773d
Cleared
Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
NGZ
Susceptibility Test Plate, Antifungal
211d
Cleared
Nov 29, 2021
SeptiCyte RAPID
PRE
Rt-qpcr Assay For Mrna Transcript Immune Biomarkers
341d
Cleared
Nov 23, 2021
Sofia 2 Campylobacter FIA
LQP
Campylobacter Spp.
204d
Cleared
Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
JWY
Manual Antimicrobial Susceptibility Test Systems
242d
Cleared
Nov 03, 2021
BD Kiestra IdentifA
QQV
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
834d
Not Cleared
Nov 03, 2021
OMNIgene GUT Dx
QPO
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
506d
Cleared
Nov 01, 2021
BioFire COVID-19 Test 2
QQX
Respiratory Specimen Nucleic Acid Sars-cov-2 Test
203d
Cleared
Oct 28, 2021
APAS Independence with IC Chromogenic MRSA BD Analysis Module
QQY
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
576d
Cleared
Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
268d
Cleared
Oct 27, 2021
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
JTN
Susceptibility Test Discs, Antimicrobial
217d
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